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The Cartiva cartilage works like a bumper over the joints and is inserted into the base of the big-toe through a drilled hole. Courtesy of Cartiva

Karen Schumman, 51, of Chesterfield Township had a Cartiva implant put into her big toe on the left foot. She is photographed on March 17, 2017 at her home.(Photo: Mandi Wright, Detroit Free Press)Buy Photo

Orthopedic surgeon Dr. Matthew Brewster had long sought abetter treatment option for his younger,still-active patients suffering from arthritic joint pain in their big toe.

The gold standard for moderate to severe big-toe arthritis a fusion of the bones could relieve their painbut permanently rob them of mobility in the toe, limiting their ability to partake in athletic activities such as jogging and, for women, wearing heels.

"I didn't like fusing 55-year-old women'stoes that want to run and wear heels," said Brewster, who practices at Associated Orthopedists of Detroit and is affiliated with Beaumont Hospital in Grosse Pointe.

So when the U.S. Food and Drug Administrationlast July approved the first synthetic cartilage-like implant as a treatmentforbig-toe arthritis, he signed up. Brewster performed his firstprocedure with the Cartiva implant that month, helping a 62-year-old Clinton Township woman regain the ability to wear shoes without pain and even go running.

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She became only the second U.S. patient to receivethe implant, which has been available in Europe for more than a decade. The first procedure was in Rochester, N.Y.

Brewster, the procedure's second U.S. doctor,has since successfully treated 13 patients with theimplant. All of them were relieved of their painand kept about half of their pre-arthritis joint mobility, he said.

Although the implant material is onlycurrently approved in the U.S. for the bigtoe,it has beensuccessfully usedto treatarthritic thumbs and knees in Canadaand Europe and offers hope for the millions ofarthritis sufferers who wish to remainactive and avoid jointreplacementsthat stealtheir mobility and require extensive surgeriesonce the deviceswear out.

An estimated 2.7 million middle-age people in the country right now have big-toe arthritis.

Brewster's patients'healthinsuranceagreed to cover the Cartiva implantand procedure costs, which aresaid to be slightly higher than a standard bone fusion.

"When he approached me with this, it sounded too good to be trueit's not," saidKaren Schumann, 51of Chesterfield Township,Brewster's most recent patient, whosebig-toe procedure was Feb. 22.

Dr. Matthew Brewster who practices at Associated Orthopedists of Detroit in St. Clair Shores and is affiliated with Beaumont Hospital, Grosse Pointe. He is the second doctor in the U.S. to do Cartiva implants.(Photo: Henry Ford Health System)

In an interview last week, Schumann recalled how her left toe had beenin increasingpainfor nearly 10 years and that she could no longerbend it. Now more than three weeks after the operation, her pain level is "zero," and sheonce again can go on long walks for exercise and go up and down stairs.

She hopes to have the same procedure done later this year on her right foot.

"I am so glad I had it done. You never realize how much you use the big toe until it hurts," Schumann said.

Headquartered outside Atlanta with 25 employees, Cartiva developed its Synthetic Cartilage Implant through research that originated out ofGeorgia Tech. The device is made of polyvinyl alcohol hydrogel, the same material as contact lenses, but is much thicker and the result ofapatented process that makes thematerial incredibly toughyet with a water content comparable to healthy cartilage. Eachimplantis expected to last many years, although the materialis still too new to makeprecise estimates.

Cartilage is a smooth,connective tissue that has a limited ability to repair itself if damaged. Researchers have been tryingfor decades to find a way to replace it. Degenerative arthritis occurs when cartilage gets worn away and bones then rubagainst each other.

"Synthetic cartilage or injectable cartilage or some type of implantable cartilage is definitely the Holy Grail of orthopedics," said Dr. Todd Irwin, a foot and ankle orthopedic surgeon at the University of Michigan Health Systemwho has done two Cartiva implant procedures.

"I think this is very promising," Irwin said, but added,"I think calling it synthetic cartilage is personally a little bit of a stretch. To me, functionally it's more of a bumper" between the bones.

Cartiva first introduced its hydrogel implantin Europe in 2002. But gaining FDA approval entailed more clinical trials and didn'thappen until last July.

Karen Schumman, 51, of Chesterfield Township had a Cartiva implant put into her big toe on the left foot. She is photographed on March 17, 2017 at her home.(Photo: Mandi Wright, Detroit Free Press)

Big-toe arthritis, known as hallux rigidus, isthe most common arthritic condition in the foot and said to affect 1 in 40 people older than 50, or roughly 2.7 million people in the U.S. Doctors say the problem can arise fromgenetics, past injuries orrepeated stress from work occupations such as flooring installation.

Yet only about 100,000 Americans each year the majority of them female getsurgical treatment for the condition, through fusions or typically metal joint implants. Those with less severe arthritis can find relief through a cheilectomy, which involves cleaning out the joint and removing bone spurs, althoughthat procedure currently rules out getting a Cartiva implant later on.

Doctors say the biggest problems with traditional implants for the big toe are therelatively high complication rates and how they often don't last beyond seven years.

The Cartiva cartilageworks like a bumper over the joints and is inserted into the base of the big-toe through a drilled hole.

Brewster said the procedure is relatively simple and takes him about 25 minutes. He considers it easier to perform than a traditional joint fusion of the toe, whichtakesmore than an hourand involves scraping out cartilage, packing in a cadaver bone graft,then screwing two bones together with a metal plate.

Patients are sedatedduring the procedure and afterward canactuallywalk out of the clinic. For two weeks theyare asked to wear a post-operative shoe, like a hard sandal. After that they can return to regularactivities.

A smallpeer-reviewed study of 27 Cartiva patients in Canada and the United Kingdom foundthat five years after theimplant,toe functionality had improved significantly in nearly everyone compared to before theirprocedure, the pain was significantly reduced and the synthetic cartilage was in good shape.

A full96% of the patients said they would undergo the procedure again.

Rosalynn Demers, 62, of Clinton Township was the first Michigan patient to receive the Cartiva implant.She had been enduring progressively worse big-toe pain for about a year and could nolonger wear most shoes because ofpain.

The Cartiva Synthetic Cartilage Implant was approved by the FDA in July 2016 to treat big-toe arthritis. (Photo: Cartiva)

"I thought it was a bunion, but it was arthritis. It was a gradual thing and then (the pain) just became ridiculous," she said. "I thought I as going to give all my shoes away, thinking that I'd never fit into them again."

She had planned to get a fusion, even thoughshe knew the procedurewould bringan end to her running hobby.Then she learned about the new FDA-approved synthetic cartilage option from her husband, Dr. Mike Demers, an orthopedic surgeon who is a colleague of Brewster's.

The Cartiva Synthetic Cartilage Implant was approved by the FDA in July 2016 to treat big-toe arthritis. (Photo: Cartiva)

In late July,Demers became the second person in the country to get theprocedure. Itwas asuccess. Not only is sheback to wearing almost all of hershoes, but she returned to running and evenraced in the Detroit Turkey Trot5K inNovember.

"I couldn't believe I ran the whole thing," she said. "It wasn't fast, but I ran it. So I thought that was pretty incredible."

Schumann, theChesterfield Township woman who just had theprocedure,recalled howBrewster demonstrated the new pain-free range of motion in her toe during a check-up appointment. Prior tothe operation, asudden movement like that would have causedsearing pain.

"All of the sudden, he bends my toe all the way down and I'm like, 'What!'" Schumann said. "He says, 'Does that hurt?' and I go, 'No you just scared me.' My toe has not been bent like that in years."

The list price of each Cartiva implant is $4,500, although hospitals can get a discount from the company.

A Beaumont representative said the Grosse Pointe hospital'stotalchargesfor the Cartiva procedure average$15,000 to $17,000. Insurance companiesthen typically pay around33% of the charges, or about $5,000, leaving the hospital to writeoff the remaining balance. Thosecharges donot include the surgeons fee, which is billed separately to insurance.

Nationwide, the averagebig toe-fusion is billed at $10,000 to $11,000 before insurance not including the surgeon's bill, according to James Laskaris, an emerging technologies senior analyst at MD Buyline, a Dallas-based firmthat provides clinical and financial information to hospitals. The surgeon istypically a $3,000 to $4,000 separatecharge, Laskaris said.

In addition tobig toes, doctors in Europe and Canada have had success using Cartiva implants to treat arthritic thumbs and knees.

Dr. Philip Sauve in the U.K. said he has treated 12 patients with thumb arthritis with a Cartiva implant. All had good results, he said.

"Thepain is reducing, their grip strength is increasingand so their function is improving," Sauvesaid in a phone interview. "So for that group who maybe is still working and still very active, I think it's a really good option."

Contact JC Reindl: 313-222-6631 or jcreindl@freepress.com. Follow him on Twitter@JCReindl.

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'Synthetic' cartilage is now an option for big-toe arthritis sufferers - Detroit Free Press

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